Regulatory consulting services for FDA submissions including 510(k), PMA, and De Novo pathways. Supports medical device companies with design control, risk management, quality system development, and compliance with ISO 13485 and MDR requirements to facilitate market approval and global product intr...
Manufactured by
TS Quality & Engineering SRL
Cantarana, Italy
TS Quality Engineering is a ISO 13485 certified company. We offer Medical Device Consulting Services and solutions aimed at facilitating, speeding up and support design, validation, regulatory processes and streamline worldwide market acces.
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